AstraZeneca announced that it has settled a lawsuit against Indian pharma giant Ranbaxy Lab in an agreement that will keep Ranbaxy's generic version of the blockbuster heartburn drug Nexium off the U.S. market until 2014.
AstraZeneca also awarded Ranbaxy some valuable contracts, which are separate from the litigation settlement. These contracts could trigger questions from the U.S. Federal Trade Commission, which still must review the agreements. The commission has objected to some deals where it believed that a patent holder was giving a generic company something of value in exchange for staying off the market, arguing that this process decrease competition and hurt consumers.
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy’s submission to the USFDA an ANDA for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product.The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014. This date marks the expiry of US5877192 and US6875872. AstraZeneca’s patents protecting Nexium have expiration dates that range from 2014 through 2019.AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.Nexium had U.S. sales of $5.5 billion last year, making it the second-biggest-selling drug, behind Pfizer Inc.'s cholesterol pill Lipitor, according to IMS Health.
In contracts AstraZeneca said were separate from the settlement, the company is allowing Ranbaxy to start making a portion of AstraZeneca's Nexium supply in May 2010. Ranbaxy will also start supplying AstraZeneca with the active pharmaceutical ingredient used to make Nexium in May 2009.
AstraZeneca is also giving Ranbaxy the right to distribute generic versions of two older AstraZeneca drugs -- Plendil for hypertension and Prilosec for heartburn -- in the U.S.
AstraZeneca still faces battles with other makers of generic drugs that are attempting to sell copies of Nexium as well as the company's drug to treat schizophrenia, Seroquel, in the U.S.
As per FDA guidelines Ranbaxy could have started selling generic Nexium this week, when a 30-month stay barring Ranbaxy from the market expired. But if Ranbaxy had started selling generic Nexium but lost the litigation, it would have to pay willful infringement damages to Astra.
AstraZeneca also awarded Ranbaxy some valuable contracts, which are separate from the litigation settlement. These contracts could trigger questions from the U.S. Federal Trade Commission, which still must review the agreements. The commission has objected to some deals where it believed that a patent holder was giving a generic company something of value in exchange for staying off the market, arguing that this process decrease competition and hurt consumers.
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy’s submission to the USFDA an ANDA for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product.The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014. This date marks the expiry of US5877192 and US6875872. AstraZeneca’s patents protecting Nexium have expiration dates that range from 2014 through 2019.AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.Nexium had U.S. sales of $5.5 billion last year, making it the second-biggest-selling drug, behind Pfizer Inc.'s cholesterol pill Lipitor, according to IMS Health.
In contracts AstraZeneca said were separate from the settlement, the company is allowing Ranbaxy to start making a portion of AstraZeneca's Nexium supply in May 2010. Ranbaxy will also start supplying AstraZeneca with the active pharmaceutical ingredient used to make Nexium in May 2009.
AstraZeneca is also giving Ranbaxy the right to distribute generic versions of two older AstraZeneca drugs -- Plendil for hypertension and Prilosec for heartburn -- in the U.S.
AstraZeneca still faces battles with other makers of generic drugs that are attempting to sell copies of Nexium as well as the company's drug to treat schizophrenia, Seroquel, in the U.S.
As per FDA guidelines Ranbaxy could have started selling generic Nexium this week, when a 30-month stay barring Ranbaxy from the market expired. But if Ranbaxy had started selling generic Nexium but lost the litigation, it would have to pay willful infringement damages to Astra.
